目的 建立一测多评法(QAMS)测定芪白平肺颗粒中8种皂苷成分的分析方法。方法 以芪白平肺颗粒为研究对象,以人参皂苷Rb₁为内参物,计算人参皂苷Re、人参皂苷Rg₁、人参皂苷Rf、人参皂苷Rc、人参皂苷Rb₂、黄芪甲苷、人参皂苷Rd与人参皂苷Rb₁的相对较正因子(f),通过f计算芪白平肺颗粒中7种成分,并在10批芪白平肺颗粒中进行验证,比较该方法与外标两点法测定结果的相似度。结果 人参皂苷Rg₁、Re、Rf、Rb₁、Rc、Rb₂、Rd、黄芪甲苷分别在进样量为0.416 0～4.992、0.315 4～3.785 2、0.259 6～3.115、0.385 2～4.622、0.222 8～2.674、0.193 2～2.318、0.183 5～2.202、0.574 6～6.895 μg线性关系良好,f值分别为1.244、1.075、1.133、1.090、1.071、1.070、0.967,且在不同条件下重复性良好。QAMS法的计算结果与外标两点法的测定结果无显著性差异,再验证结果也无显著性差异,实验所得的f值可信。结论 建立的QAMS可以准确、快速地实现芪白平肺颗粒中多种皂苷类成分的定量测定。

Objective To establish a quantitative analysis of multi-components with a single-marker (QAMS) method for the determination of eight components in Qibai Pingfei Granule (QPG). Methods Ginsenoside Rb₁ was used as the internal reference substance. The relative correlation factors (f) of ginsenosides Rg, Re, Rf, Rc, Rb₂, Rc, and astragaloside were calculated and established. The results were compared with those obtained by the external standard method in 10 batches of QPG. The results showed that the f values of ginsenosides Rg, Rf, Rc, Rb₂, astragaloside, and ginsenosides Rc to ginsenoside Rb₁ were 1.244, 1.075, 1.133, 1.090, 1.071, 0.967 and 1.070. Results Ginsenosides Rg₁, Re, Rf, Rb₁, Rc, Rb₂, Rd, and astragaloside had good relations within the ranges of 0.416 0-4.992, 0.315 4-3.785 2, 0.259 6-3.115, 0.385 2-4.622, 0.222 8-2.674, 0.193 2-2.318, 0.183 5-2.202, and 0.574 6-6.895 μg, respectively. The two methods did not show the significant difference in assay results. Conclusion So the QAMS method is feasible and credible, and could be used to determine the multiple components in QPG.

现代中药创新集群与数字制药技术平台(2013ZX09402203)